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REMS Audits and Inspections

REMS Audits and Inspections: What You Need to Know

Blogs, Pharmacovigilance /

Risk Evaluation and Mitigation Strategies (REMS) are special safety programs required by the U.S. Food and Drug Administration (FDA) for certain drugs and biologics with serious safety concerns. These programs are designed to ensure that a product’s benefits outweigh its risks. REMS may include strategies such as restricted distribution, prescriber certification, patient education, training, and […]

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Key Developments & Implications of the European Health Data Space

Blogs, Pharmacovigilance, Regulatory /

In an age where data is often called the new oil, the healthcare sector is sitting on a goldmine of untapped potential. Every day, vast amounts of health data are generated across the European Union, offering incredible opportunities to transform the way healthcare is delivered, researched, and managed. Enter the European Health Data Space (EHDS)—a

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Challenges Risk Assessment in Veterinary

Navigating the Complexities of Risk Assessment in Veterinary Pharmaceuticals 

Blogs, Pharmacovigilance, Regulatory /

The development of veterinary medicines faces numerous challenges that are unique compared to human pharmaceutical development. Although the pharmaceutical industry in both sectors is built on shared principles of safety and efficacy, the veterinary pharmaceutical industry is confronted with a significantly more complex risk environment. The distinctive risk assessment challenges of veterinary pharmaceuticals and how

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Roadblocks in Global Pharmacovigilance Harmonization

Overcoming Roadblocks in Global Pharmacovigilance Harmonization

Blogs, Pharmacovigilance /

Pharmacovigilance (PV) is defined by the World Health Organization (WHO) as “the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem”. Global Pharmacovigilance Harmonization, on the other hand, refers to the process of aligning regulations, practices, and standards across countries and regions in order to

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pharmacovigilance approach for biosimilars market

Pharmacovigilance Approaches for Biosimilars Market Success 

Blogs, Pharmacovigilance /

The pharmaceutical field has witnessed a tremendous growth of innovation and success in the past few years. Among these advancements, biosimilars have become essential for improving patient access and reducing the cost of therapies. The complexities that even a slight manufacturing differences can lead to variations in protein structure, post-translational modifications, and glycosylation patterns. Since

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Current Trends patient engagement in healthcare

Patient Engagement in Healthcare: Current Trends and Future Opportunities

Blogs, Clinical Regulatory, Medical Writing, Pharmacovigilance, Regulatory /

For years, the focus of healthcare development and delivery has been on treatment and outcomes, often with limited input from patients. However, there is now a growing recognition that patients should not just be passive recipients of care—they should be active participants in their own healthcare journey. This patient-centered approach is transforming the way drugs

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personalized drug in development

Navigating the Challenges of Personalized Medicine in Development

Blogs, Clinical Regulatory, Pharmacovigilance, Regulatory /

The landscape of modern medicine is undergoing a revolutionary transformation, with personalized medicine at the forefront. As we move away from the “one-size-fits-all” approach and embrace treatments tailored to individual genetic profiles, lifestyle, and environmental factors, the potential to improve patient outcomes has never been greater. However, this evolution also comes with unique challenges, particularly

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Role of Real-World Evidence in Post-Marketing Safety

Leveraging Real-World Evidence to Enhance Post-Marketing Safety Globally

Blogs, Pharmacovigilance, Regulatory /

Real-World Evidence (RWE) refers to clinical evidence regarding the usage and potential benefits or risks of a medical product, derived from the analysis of Real-World Data (RWD). RWD encompasses information collected from various sources, including electronic health records (EHRs), insurance claims, patient registries, and data from mobile health applications. This evidence is crucial in understanding

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Concept of Patient-Centric Pharmacovigilance

How Pharmacovigilance is incorporating the concept of Patient Centricity – An Industry-Leading Approach

Blogs, Pharmacovigilance /

In healthcare, assuring the safety of medications is equally as vital to developing innovative new treatments. Pharmacovigilance (PV), or “drug safety surveillance”, is the science of detecting, assessing, and preventing adverse drug effects or any related problems from drugs that has traditionally focused on data from healthcare providers, clinical trials and regulatory agencies. Development of

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Pharmacovigilance Strategies for Rare Disease Drugs

Advanced Pharmacovigilance Strategies for Rare Disease Drugs

Blogs, Pharmacovigilance /

Rare diseases (also referred to as orphan diseases) are diseases that affect less than 5 in 10,000 people in Europe or fewer than 200,000 people in the United States. Although each rare condition affects only a small population, it collectively affects more than 350 million people worldwide and can severely affect a patient’s quality of

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